A Phase III, Randomized, Double-blind, Parallel-group, Placebo controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab in Pediatric Participants 5 to < 18 Years of Age with Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy

Moderate to Severe Active Systemic Lupus Erythematosus

After single dose or after dose adjustment: PK: Cmax; AUC; Cmin after the first dose or after dose adjustment Predicted steady-state Css, max, AUCss, Css, avg, BICLA responders at W52 (Y/N), defined as follow: Reduction of all baseline BILAG A to B/C/D & B to C/D & no BILAG worsening in other organ systems (≥ 1 new BILAG A or ≥ 2 new BILAG B) No worsening from baseline S-2K (increase of > 0 points) No worsening from baseline in SLE activity (increase ≥ 0.30 points on a PGA 3-point VAS)

SRI(4) responders at Wk. 52 (Y/N): meet all the following: Minimum 4-point reduction from baseline (BL) SLEDAI2K score No new BILAG-2004 (BILAG) scores from BL (≥ 1 new A or ≥ 2 new BILAG B scores) No worsening in BL lupus disease activity (increase ≥ 0.30 points on a PGA 3-point VAS), Time to first flare through Week 52, where flare is defined as either ≥ 1 new BILAG-2004 A, or ≥ 2 new BILAG-2004 B items compared with the previous visit., Change from baseline through Week 52 in: Anifrolumab serum concentration ADA Anti-dsDNA antibodies C3, C4, and CH50 complement levels Type I IFN 21-gene signature, Participants who are PRINTO/ACR cSLE responders (Y/N) at W52, defined as at least 50% improvement from baseline in any 2 of 5 core set outcome measures and no more than one of the remaining worsening > 30% The core set measures are: ParentGA 21-circle VAS PGA 3-point VAS S-2K PedsQL Generic Core (Physical Functioning Domain) Proteinuria, Reduction of OCS background dose from baseline through Week 52

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